# Safety & PV Specialist I - Literature Case processing **Company**: Syneos Health **Experience**: mid **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---PV-Specialist-I---Literature-Case-processing_25111538?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_591c54f4-066 ## Description Syneos Health is seeking a Safety & PV Specialist I - Literature Case processing. As a Safety & PV Specialist, you will be responsible for processing and evaluating Individual Case Safety Reports (ICSRs) and performing literature screening and review for safety. **Job Responsibilities:** - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required - Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability - Enter data into safety database - Code events, medical history, concomitant medications, and tests - Compile complete narrative summaries - Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved - Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements - Maintain safety tracking for assigned activities - Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required - Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA - Manually recode un-recoded product and substance terms arising from ICSRs - Identify and manage duplicate ICSRs - Participate in activities related to SPOR / IDMP - Conduct quality review of ICSRs - Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate - Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process - Foster constructive and professional working relationships with all project team members, internal and external - Participate in audits as required/appropriate - Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities **Qualifications:** - 2+ years of experience in Literature Data entry along with MLM experience - M.Pharma / BDS / Pharm D Degree or Equivalent - Safety Database systems and knowledge of medical terminology required - Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance - Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet - Ability to work independently and in a team environment - Excellent communication and interpersonal skills, both written and spoken - Good organizational skills with proven ability to prioritize and work on multiple tasks and projects - Detail-oriented with a high degree of accuracy and ability to meet deadlines ## Skills ### Required - Medical Terminology - Safety Database systems - Microsoft Office Suite - Visio - MedDRA coding - SPOR / IDMP - ICH GCP - GVP ### Nice to have - MLM experience - Literature Data entry experience --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---PV-Specialist-I---Literature-Case-processing_25111538?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)